engleski

Twin Birth Study

AIM: To conduct a multicentre international RCT, comparing planned caesarean section (CS) to planned vaginal birth (VB) for twins at 32 - 38 weeks gestation. METHODS: Selection criteria: Inclusion: twins at 32 - 38 weeks gestation with twin A presenting vertex, both twins alive, and estimated fetal weight 1500-4000g. Exclusion: monoamniotic twins, lethal anomaly of either twin, contraindication to labour or VB. Timing of Randomisation: Randomisation will be carried out at 32 weeks, allowing for planning of the delivery and birth. Eligible consenting women presenting in labour or with an indication for urgent delivery may also be randomised at 32 - 38 weeks. Timing and Method of Delivery: Because there is an increase in stillbirth rate after 38 weeks gestation, trial participants will be delivered by the planned method of delivery at 38 weeks. Vaginal delivery will be conducted by experienced personnel: if twin B is non-vertex the initial options for delivery are: i) spontaneous or assisted vaginal breech delivery (if breech) ; ii) total breech extraction with or without internal podalic version ; or iii) external cephalic version and vaginal delivery of the fetus as a vertex. Outcomes: Primary: perinatal or neonatal mortality and/or serious neonatal morbidity (excluding lethal congenital anomalies). Secondary: i) death or poor neurodevelopmental outcome of the children at 2 years of age ; ii) problematic urinary or faecal/flatal incontinence for the mother at 2 years postpartum. Others: Maternal death or serious maternal morbidity within 28 days following delivery ; maternal satisfaction with method of delivery (3 months) ; breast feeding (3 months) ; maternal quality of life (3 months & 2 years) ; problematic urinary or faecal/flatal incontinence at 3 months ; costs. Sample Size: A sample of 1400 pregnancies/group will be adequate to find a reduction in risk of perinatal or neonatal mortality or serious neonatal morbidity from 4% to 2% with a policy of planned CS, if such a reduction exists (power = 80%, 2-sided  error = 0.05). To enrol 2800 women over 4.5 years, approximately 120 centres are required. RESULTS: To date, more than 50 centres in 20 countries have joined the study and 145 centres have indicated their interest in joining. Recruitment of eligible women began in December 2003. Additional centres are welcome. CONCLUSION: TBS will answer a question of importance to women, clinicians and policy makers, and should be undertaken before, in the absence of evidence, CS becomes the standard of care for women with twins.

twin pregnancy; delivery; planned caesarean section; planned vaginal birth; neonatal morbidity; neurodevelopmental outcome

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